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Laura writes ...

Monday, March 14, 2016

If you're a tennis fan or someone who follows the myriad of doping issues, you've undoubtedly heard of the doping case of Maria Sharapova. One of the issues raised by Sharapova's lawyer is that she could pursue a retroactive Theraputic Use Exemption(TUE). A TUE is an option for athletes who have a medical condition that requires use of a substance that is also on the WADA banned list.

The following is the opinion of Dr. Ken Fitch, an Australian professor who has extensive experience with setting up the rules for TUE's within the Olympic movement. This topics relevance to all sports is the requirements that must be met to be granted a TUE in any sport.

The following was submitted by Dr. Ken Fitch, an
Australian doctor and Professor, School of Sports Science,
Exercise and Health, Faculty of Life Science University of Western Australia. Dr.
Fitch also wrote the rules for TUEs in 1991 for the IOC, chaired the IOC's TUE
Committee for 20 years, chaired WADA's interim committee (2001-2003) that
established the initial International Standard for TUE (2004) and chaired my
national TUE Committee for 22 years.

The ludicrous suggestion by Sharapova’s lawyer that
she might seek a retroactive Therapeutic Use Exemption (TUE) to avoid a
sanction for testing positive to meldonium demands a response. Ignoring
whether the 2016 World Anti-Doping Code and the 2015 International Standard for
TUEs does or does not make a retroactive TUE a possibility in her
circumstances, if anybody examines the criteria that must be met to grant a
TUE, he/she would understand that no respectable TUE Committee could approve
any such application.

WADA states that there are four criteria, all of
which must be met to grant a TUE.

The drug
is necessary to treat an acute or chronic medical condition and the
athlete would experience a significant impairment to health if it were to
be withheld

The
therapeutic use of the prohibited drug is highly unlikely to produce any
additional enhancement of performance beyond what might be anticipated by
a return to the athlete’s normal state of health following the treatment

There is
no reasonable therapeutic alternative to the use of the prohibited drug.

The necessity to use of the prohibited drug is not a consequence of
prior use of a prohibited drug or method

Would Sharapova’s health be significantly impaired if
she was denied a TUE?

The Latvian makers of meldonium advise that it should
be taken in intermittent courses of 4-6 weeks and for what period of time
Sharapova administered meldonium during the past 10 years, has yet to be
disclosed. As the only acceptable medical indications are for ischemic
cardiac and ischemic cerebral conditions, it is unthinkable that Sharapova has
either. Hence any claim that should she be denied the right to take
meldonium would impair her health is simply fanciful. Any TUE application
must fail criterion 1.

The second criterion was introduced because some
athletes had an essential need to take a prohibited drug. For example, an
insulin dependent diabetic would die if denied insulin which has been
prohibited in sport since 1998 and their daily insulin injections that are
permitted with a TUE do not enhance performance. Whether meldonium
actually enhances performance in humans has yet to be demonstrated. That
WADA has advised that in less than two months since it was added to the
Prohibited List, 99 athletes have tested positive for meldonium would appear to
indicate that many athletes and their advisors believe that it does. No
athlete could claim that meldonium was essential to restore their health back
to normal levels. To claim that without it, a person’s health would be
less than normal is surely fictitious. Fails criterion 2

There are many drugs that have been demonstrated in
scientific trials to be valuable in cardiac ischemia and the vast majority
would be far superior to meldonium. The few meldonium studies performed
in humans have been on persons who recently had experienced a myocardial
infarction or an acute coronary syndrome. That the makers of meldonium
recommend that it is administered only in intermittent courses in contrast to
most of the widely acceptable, prescribed alternatives that are to be taken
daily, is further evidence of the non-essential status of meldonium to treat
cardiac ischemia. As the drug is marketed in only 10 countries globally
and Sharapova has lived in USA for much of her life where meldonium is not
approved for human use, this poses further questions for the tennis
player.

Drug therapy for cerebral ischemia is generally
ineffective and less frequently used than for cardiac ischemia but those
patients on whom meldonium was trialled had had either a recent stroke or
evidence of deteriorating brain function. As Sharapova could not possibly
demonstrate that she has either of these or indeed significant cardiac or
cerebral ischemia, and if she could, alternative permitted drugs are at least
as effective if not more so, she fails criterion 3.

Hence Sharapova fails 3/3 and the fourth criterion has
no relevance.

Finally, should an unscrupulous or ignorant TUE
Committee happen to grant Sharapova a retroactive or even a prospective TUE for
meldonium, WADA would be certain to appeal to CAS and the decision would be or
should be overturned.